Study for Using Radiosurgery on Limited Metastases of Breast Cancer

A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer

The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.

Study Overview

• Status: Completed
• Conditions: Breast Cancer, Metastatic
• Intervention / Treatment: Procedure: Hypofractionated Stereotactic Body Radiation Therapy; Radiation: Hypofractionated Stereotactic Body Radiation Therapy

Detailed Description

Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Department of Radiation Oncology: University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age: no limit
• Karnofsky performance status (KPS) ≥ 70
• No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
• The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.
• Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.
• Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.
• Informed consent must be obtained.
• Pregnancy test must be negative for women of child bearing potential

Exclusion Criteria:

• Inability of patient to be followed longitudinally as specified by protocol.
• Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
• Women who are pregnant or nursing.
• Failure to meet requirements in Inclusion Criteria
• Contraindications to radiation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypofractionated Stereotactic Body Radiation Therapy; Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.	Procedure: Hypofractionated Stereotactic Body Radiation Therapy; Hypofractionated Stereotactic Body Radiation Therapy; Radiation: Hypofractionated Stereotactic Body Radiation Therapy; Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The percent of patients that survived from date of enrollment until 2 year follow-up visit.	2 years
Overall Survival	The percent of patients that survived from date of enrollment until 4 year follow-up visit	4 years
Overall Survival	The percent of patients that survived from date of enrollment until 6 year follow-up visit	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients With Lesion Local Control	Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.	6 years
Number of Participants Who Experienced a Grade 4 or 5 Toxicity	Number of participants who experienced a grade 4 or 5 toxicity	6 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Hong Zhang, MD, University of Rochester

Publications and helpful links

Helpful Links

• Click here for more information about this study: Using Radiosurgery On Limited Metastases Of Breast Cancer

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2000
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: conformal radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: URCC 8700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO